A technical compliance management system can help to reduce the risk of product-related
binding technical obligations. When introducing such a system, there are various points to
consider that can be an essential lever to success. This includes, among other things, a clear
understanding of the interfaces to compliance, legal, quality and R&D and the risk-based
approach to defining the focus of the tCMS. The following article will go into these points
in more detail.

Increasingly stringent regulatory demands for product compliance and the growing number of sustainability requirements put companies under increasing pressure. How can development, production, and sales meet the rising expectations? Product Lifecycle Management (PLM) and Product Compliance Management Systems (PCMS) offer forward-looking solutions to master this complexity. The combination of PLM and PCMS breaks down information silos and enables close collaboration across departmental boundaries—the result: more innovation, efficiency and safety.

Punctuality, customer satisfaction, and a shortage of skilled workers: These are the key challenges currently facing Deutsche Bahn. How can digitalization, automation, and targeted deployment of artificial intelligence (AI) help master them? As the following insight into Deutsche Bahn’s digital transformation shows, there are many applications where AI can play a role – ranging from routine processes to AI-driven process optimization right through to AI-driven analysis of social media channels.

In just three years, Danish facility management services group ISS, which has over 350,000 employees, has taken its digital transformation to a new level, turning a small IT support function into a global, agile IT organization. Technology is now a clear USP for the ISS brand. Digital products developed in-house complement the group’s traditional services of cleaning, food services, facility management, and workplace experience. None of this would have been possible without the cloud, the Internet of Things (IoT), and AI.

Yesterday, chatbots. Today, video AI. Tomorrow, a seat on the board? Technology is more important than ever. Generative AI has disrupted the market at a pace that was unimaginable until recently. Meanwhile, the cloud is paving the way for more technological revolutions. These developments are radically changing how companies work – from product development right through to aftersales. What are the organizational and operational factors that you should consider if your business is to generate value going forward?

In today’s rapidly evolving technology landscape, organizations must not only keep pace with the latest advancements, such as AI, Cloud, Data Analytics, and Metaverse, but also assess their potential and impact on operations. To navigate this complex terrain, the role of the Chief Information Officer (CIO) and their respective IT organizations have become more critical for the company’s success than ever. This article explores the evolving role of the CIO in advancing a technology-enabled organization and discusses key elements that drive success at the Electronics business of Merck KGaA, Darmstadt, Germany.

Die deutsche Pharmaforschungslandschaft zeichnet sich durch eine große Bandbreite an medizinischen Ausrichtungen und technologischen Kompetenzen aus. Die forschenden Unternehmen geben hier jährlich mehr als 9,4 Milliarden Euro für Forschung und Entwicklung aus. Dennoch schöpft Deutschland sein Potenzial noch nicht aus, insbesondere im Bereich klinischer Arzneimittelstudien. Einige der zugrundliegenden Handicaps werden aber inzwischen politisch angegangen.

Mit der steigenden Komplexität des Gesundheitswesens müssen forschende Arzneimittelhersteller neue Wege gehen. Ein Ansatz, der immer mehr Aufmerksamkeit gewinnt, ist die frühzeitige Einbindung von Endkonsumenten – also Patient:innen – und ihren Bedarfen in der Entwicklung von klinischen Studien. Roche zeigt, wie eine frühe und konsequente Einbindung von Patient:innen zu qualitativ besseren Forschungsergebnissen sowie einer schnelleren und breiteren Markteinführung mit zufriedeneren Kund:innen führt.

Komplexität in der Entwicklung neuer Therapien bindet immer Kapazitäten bei allen beteiligten Partnern, Forschern, Industrie und Behörden. Ein Teufelskreislauf, der über Partner hinweg eingegrenzt werden sollte.

Die Pharmaindustrie hat in den letzten Jahren beeindruckende Durchbrüche erzielt. Dennoch stehen CEOs mehr denn je unter hohem Innovationsdruck. Patentabläufe und striktere regulatorische Rahmenbedingungen zwingen sie zu immer höheren Investitionen in Forschung und Entwicklung, um den Renditeerwartungen des Kapitalmarkts gerecht zu werden. Die Folge ist ein verschärfter Wettbewerb, der die gesamte Branche vor neue Herausforderungen stellt und neue Denkweisen erfordert.